From what I remember reading, you need the approval to proceed with clinical trails first. Though, we could have received that at any time, since the FDA has no requirements for publishing that information. They could come at the same time, weeks apart, or a month apart.
I would assume he would space them out, regardless of when we would have received approvals.
It is not possible for any of us to know for certain whether they have filed for orphan drug status yet or not. According to the FDA protocol you can file for orphan drug status at any point within the filing (including prior to IND approval). Therefore it would make the most sense to file for it as soon as possible; I personally believe that they have filed for it already.
§316.20 Content and format of a request for orphan-drug designation.
(a) A sponsor that submits a request for orphan-drug designation of a drug for a specified rare disease or condition shall submit each request in the form and containing the information required in paragraph (b) of this section. A sponsor may request orphan-drug designation of a previously unapproved drug, or of a new use for an already marketed drug.
§316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
(a) A sponsor may request orphan-drug designation at any time in its drug development process prior to the time that sponsor submits a marketing application for the drug for the same rare disease or condition.
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